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The Bio2 Fusion Implant System is indicated for fracture fixation, osteotomies, and inter-digital fusion of the fingers, toes and small bones in the presence of appropriate immobilization.

When used in the foot (including hammertoe, claw toe, and mallet toe) patients should use protected weight bearing or heel bearing until fusion or healing has occurred.

The Bio2 Technologies Fusion Implant is a cylindrical shaped implant designed for fracture fixation repair, osteotomy and to fit into the proximal and distal sides of the proximal interphalangeal joints of the foot or hand. The implants are made of bioactive glass material that has been demonstrated to be biocompatible and osteoconductive. The implants are available in multiple diameters, lengths and in a straight and angled configuration. The implants are provided sterile and are intended for single use.

The provided text describes the Bio2 Fusion Implant System, a medical device intended for fracture fixation, osteotomies, and inter-digital fusion of fingers, toes, and small bones. The document is a 510(k) premarket notification from the FDA, aiming to demonstrate substantial equivalence to previously marketed predicate devices.

However, the document does not contain the kind of detailed information requested about the acceptance criteria and the study that proves the device meets those criteria, specifically for an AI/CADe device. The Bio2 Fusion Implant System is a physical implant, not a software or AI-based diagnostic tool.

Therefore, for this specific input, the following requested information cannot be provided as it is not present in the document:

1. A table of acceptance criteria and the reported device performance: Not applicable as this is a physical implant, and the performance testing described is mechanical, not related to AI metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for an AI test set. The document mentions "performance testing" of the implant but doesn't detail sample sizes or data provenance in the context of AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a physical implant; ground truth establishment as it pertains to AI/diagnostic accuracy is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI device. The ground truth for biocompatibility and mechanical properties would be in vitro/in vivo assays and mechanical testing results.
8. The sample size for the training set: Not applicable, as there is no AI algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

Information that is available in the document regarding traditional device testing:

Performance Data Mentioned:
The document states: "Performance testing supports the substantial equivalence of the subject device to the predicate device."

• Biocompatibility: Established according to blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing."
• In vitro bioactivity testing: (ISO 23317:2012) showed the material forms a surface apatite layer when submerged in simulated body fluid.
• Mechanical Testing: "Static and fatigue bending tests and in vitro stability tests were conducted on the subject and predicate devices to demonstrate substantial equivalence."

Type of Ground Truth Used (for a physical device):
For biocompatibility, the ground truth would be established through standard biological evaluation methods and outcomes per ISO-10993. For bioactivity, the formation of a surface apatite layer in simulated body fluid per ISO 23317:2012 is the ground truth. For mechanical performance, established engineering standards for static, fatigue, and stability tests serve as the ground truth.

Sample Sizes for these physical tests are not specified in this summary document.
Data Provenance (for physical device testing): Not specified beyond the tests being conducted on "the subject and predicate devices."

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The PHALINX® Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PHALINX® Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The PHALINX® Hammertoe System implants are a single piece titanium device offered in straight cannulated and 10° solid options. The implants have proximal and distal fixation features and are offered in multiple sizes. This submission seeks to add PHALINX® K-Wires to the system for use with cannulated implants. The PHALINX® K-wires are offered in surgical grade stainless steel. A range of diameters and lengths are offered from the manufacturer and planning should be conducted prior to implantation to determine the best fit.

This document is a 510(k) premarket notification for a medical device called the "PHALINX® Hammertoe System." It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria as would be expected for an AI/software as a medical device (SaMD).

This document is for a physical orthopedic implant system, not a software or AI device. Therefore, the requested information categories regarding acceptance criteria, performance studies, sample sizes, ground truth, experts, and MRMC studies, which are typical for SaMD, are not applicable here.

The document primarily focuses on establishing "substantial equivalence" to predicate physical devices, meaning it is similar enough in design, materials, and intended use that it does not raise new questions of safety or effectiveness.

Here's a breakdown of what is available in the document, framed against your request, to highlight the absence of SaMD-specific information:

1. A table of acceptance criteria and the reported device performance:

   • Not applicable / Not present. This submission does not provide acceptance criteria for a performance study as might be done for SaMD. Instead, it relies on substantial equivalence.
   • The document states: "Testing related to bending and pull-out strength was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical." This implies that the current device is considered to meet the same performance characteristics as its predicates based on its identical design.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not present. There is no "test set" in the context of an AI/software evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable / Not present. "Ground truth" in the context of an AI/software evaluation is not relevant for this physical device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / Not present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable / Not present. MRMC studies are specific to evaluating AI in diagnostic contexts.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable / Not present. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable / Not present.

8. The sample size for the training set:

   • Not applicable / Not present. No "training set" for an algorithm.

9. How the ground truth for the training set was established:

   • Not applicable / Not present.

Summary of Device and its Basis for Clearance:

• Device Name: PHALINX® Hammertoe System
• Intended Use: Fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants can be used with K-wires for delivery or temporary stabilization of outlying joints.
• Device Description: Single-piece titanium device (straight cannulated and 10° solid options) with proximal and distal fixation features, offered in multiple sizes. This submission specifically adds PHALINX® K-Wires (surgical grade stainless steel) for use with cannulated implants.
• Basis for Clearance (Substantial Equivalence): The device design is stated to be "identical to the currently marketed PHALINX® Hammertoe System." Therefore, new performance testing (like bending and pull-out strength) was not provided, as it was previously submitted for the predicate device.
• Clinical Evidence: "N/A" (Not Applicable)
• Conclusion: The design characteristics "do not raise any new types of questions of safety or effectiveness." The device is expected to perform "at least as well as the predicate device."

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